IBI343 in Combination With Sintilimab and SOX Regimen for Perioperative Treatment of Resectable, … (NCT07483567) | Clinical Trial Compass
RecruitingPhase 2
IBI343 in Combination With Sintilimab and SOX Regimen for Perioperative Treatment of Resectable, Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
China90 participantsStarted 2026-04-17
Plain-language summary
This study is a prospective, randomized, open, multicenter phase II clinical trial. It plans to enroll 70 participants with locally advanced gastric and gastroesophageal junction adenocarcinoma (G/GEJ AC) who are assessed as suitable for D2 radical surgery and capable of R0 resection.To evaluate the clinical efficacy and tolerability of IBI343 in combination with sintilimab and SOX regimen for perioperative treatment of resectable, locally advanced gastric or gastroesophageal junction adenocarcinoma.Enroll patients who are CLDN18.2 positive.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Signed written informed consent and able to comply with the visit and related procedures as specified in the protocol.
. Male or female, 18 years ≤ age ≤ 75 years;
. ECOG score 0-1;
. Histologically confirmed, previously untreated patients with gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction; only Siewert II/III type participants are allowed for gastroesophageal junction cancer;
. Clinical staging based on enhanced CT/MRI examination, clinical stage T3\~4a with positive lymph nodes, and no distant metastasis;
. The research center and surgeon can perform radical D2 lymph node dissection surgery, R0 resection;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pathological complete response rate (pCR rate): defined as the proportion of participants who, after surgery, show complete regression of tumor cells in the primary lesion and lymph node lesions according to pathological examination.
Timeframe: Up to 4 years
2
Dose-limiting toxicity (DLT), to determine MTD and/or RP2D
. Physical condition and organ function allow for major abdominal surgery;
. Confirmed CLDN18.2 expression by central laboratory pathological tissue testing.
Exclusion criteria
. HER2 positive.
. Currently participating in another interventional clinical study, except for those in the follow-up phase of an interventional study.
. Previous use of traditional Chinese medicine, Chinese patent medicines, or immunomodulators must be ≥2 weeks before starting the study medication.
. Received treatment with a strong CYP3A4 inhibitor within 2 weeks or 5 half-lives (whichever is longer) prior to the first dose of the study drug.
. Received any live vaccine within 4 weeks prior to the first dose of the study drug or plans to receive any during the study period.
. Underwent major surgery (craniotomy, thoracotomy, laparotomy, laparoscopic resection of significant tissues or organs, or other as defined by the investigator, excluding needle biopsies) within 4 weeks prior to the first dose of the study drug, or has unhealed wounds, ulcers, or fractures.
. Patients who received steroids (\>10 mg/day prednisone equivalent) or other immunosuppressive drugs within 14 days before enrollment. However, patients are allowed to enroll if they use topical or inhaled steroids, or adrenal replacement therapy with ≤10 mg/day prednisone equivalent, without active autoimmune disease.
. History of interstitial lung disease, non-infectious pneumonia, severely impaired pulmonary function, or uncontrolled pulmonary disease such as pulmonary fibrosis, severe radiation pneumonitis, acute lung injury, etc., or suspected of having such conditions during the screening period.